Pregnancy Complications from Herceptin, PERJETA, and KADCYLA

Herceptin: Taking Herceptin during pregnancy can result in reduced amniotic fluid (oligohydramnios), in some cases complicated by incomplete development of the lungs (pulmonary hypoplasia), and death of the newborn child. Please see the full Prescribing Information for Herceptin, including Boxed WARNINGS.

PERJETA: Exposure to PERJETA can result in embryo-fetal death and birth defects. Studies in animals have resulted in reduced amniotic fluid (oligohydramnios), delayed development of the kidneys, and death. Please see the full Prescribing Information for PERJETA, including Boxed WARNINGS.

KADCYLA: KADCYLA can cause harm to the unborn child when administered to a pregnant woman. There are no adequate and well-controlled studies of KADCYLA in pregnant women, and no reproductive and developmental toxicology studies have been conducted. Nevertheless, the two components of KADCYLA (trastuzumab and DM1) are known or suspected to cause fetal harm or death when given to a pregnant woman.

Treatment with trastuzumab, the antibody component of KADCYLA, during pregnancy in the postmarketing setting has resulted in reduced amniotic fluid (oligohydramnios), in some cases associated with fatal pulmonary hypoplasia, skeletal abnormalities, and death of the newborn child. DM1, the cytotoxic component of KADCYLA, can be expected to cause embryo-fetal toxicity based on how it works. Please see the full Prescribing Information for KADCYLA, including Boxed WARNINGS.

Contact Us to Start Enrollment

To start the enrollment process, you can contact the registry in the following ways:

Phone: 1-800-690-6720

Fax: 1-800-800-1052

Email:
pregnancyregistries@incresearch.com

Mailing Address:
The MotHER Pregnancy Registry
INC Research
301 Government Center Drive
Wilmington, NC 28401



Disclaimer

By using this web site you acknowledge that INC Research is providing the material for informational purposes only and that neither INC Research and its subsidiaries, divisions and affiliates (together, the "Company") are providing the materials to you for the purposes of giving medical advice. This web site has been compiled in good faith by the Company. However, no representation is made as to the completeness or accuracy of the information it contains. In particular, you should be aware that the information may be incomplete, may contain errors or inaccuracies, or may have become stale. The press releases and reports filed by the Company with the Securities and Exchange Commission and listed on this web site speak only as of the respective dates on which they are released, filed or used by the Company. The contents of these releases and reports can and often will become out-of-date. The Company makes no commitment, and disclaims any duty or responsibility, to update any of those press releases or reports. The Company reserves the right to update, add, modify, and delete any information at this web site at any time and from time to time without notice. The periodic reports INC Research files with the SEC may include therein certain disclosures of factors that may affect the Company’s future performance. These statements are intended to be read only in conjunction with the complete documents in which they appear. The information provided on this web site and any references to products or services are provided on an "as is" basis for informational purposes only without any warranties or implied terms of any kind, which are hereby disclaimed, including, without limitation, the implied warranty of merchantability, fitness for a particular purpose or non-infringement of proprietary rights.

Close

Thank you for submitting your email information.

A registry representative will be in touch with you to finalize enrollment details and respond to any question you may have.

MotHER Registry Update

At this time, the registry is not accepting new participants and will be shutting down. Please report the pregnancy directly to Genentech via the AE reporting line at 1‑888‑835‑2555, or to the FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.

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Do I Need Authorization From My Patients ?

Do I Need Authorization From My Patients ?

This registry was required by the FDA and is exempt from HIPAA authorization requirements. Under 45 Code of Federal Regulations (CFR)-164.512(b)(1)(iii) of the HIPAA regulations, an authorization is not required for disclosure of health information for purposes related to the quality, safety, or effectiveness of an FDA-regulated therapy. This regulation applies to the MotHER Pregnancy Registry.

Informed consent (either verbal or written) is required. Healthcare professionals will not be able to enroll their patients without informed consent being obtained. They are allowed to review the ICF with their patients and then submit the signed document. The registry also requires medical releases to be able to contact any healthcare professional.

Need to fax forms to the registry?

Fax the registry at 1-800-800-1052.